Clinical trial of herbal formulation improving respiratory immunity in children.
Not Applicable
Completed
- Registration Number
- CTRI/2021/07/034779
- Lead Sponsor
- Siddhayu Ayurvedic Research Fdn Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Healthy children of either sex of 3-13 years (both inclusive)
Ready to provide informed consent from parent/ legally accepted Guardian
No significant medical or surgical disease/s at the time of screening
No history of allergic conditions at screening by the related ingredients like investigational product
Willing to come for the follow up visits for evaluation
Exclusion Criteria
Presence of any clinically significant medical or surgical condition requiring long term treatment
Subjects participating/participated in another clinical study within 3 months before recruitment
Evidence of significant uncontrolled concomitant disease which in the Investigators opinion would preclude patient participation
Immunologically compromised children
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of episodes, severity and duration of illness during the study period <br/ ><br>Complete Hemogram <br/ ><br>Serum IgG, IgM <br/ ><br>Levels of CD3,4 and 8 cells <br/ ><br>Timepoint: On screening day 15 and day 30
- Secondary Outcome Measures
Name Time Method Digestive behavior questionnaire analysis <br/ ><br>Assessment of energy and stamina in parent reported questionnaire <br/ ><br>Drug compliance <br/ ><br>Tolerability of study drugs <br/ ><br>Adverse events/ Adverse drug reactions <br/ ><br>Timepoint: On screening day 15 and day 30